MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY RES 44200 VENTRICULOSTOMY BH 6MM REG IMP; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 44200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 03/04/2022

Event Type  Injury  

Manufacturer Narrative

No products have been returned to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a intracerebral ventriculostomy (icv) set.It was reported that on (b)(6) 2016, the patient initiated treatment with a non-medtronic product.The most recent dose was administered on (b)(6) 2022.On (b)(6) 2017, the patient underwent implantation of a medtronic icv set.On (b)(6) 2022, the patient experienced a grade 1 device-related infection.The patient had cerebrospinal fluid (csf) culture results on (b)(6) 2022 of rare white blood cells with no organisms seen.On (b)(6) 2022, the patient's positive csf culture was confirmed from the csf culture collected on (b)(6) 2022.The csf culture on (b)(6) 2022 had revealed rare curtibacterium (formerly propionibacterium) acnes - in thioglycolate broth only - with susceptibility to follow.Treatment for the event included vancomycin.The outcome of the event was reported as resolving/recovering.It was noted that this is a known complication with icv use.The patient's past medical history was not reported.The patient's concurrent conditions included: neuronal ceroid lipofuscinosis, nystagmus, ataxia, sars-cov-2 test positive, intention tremor, hypotonia, and dysmetria.No allergies were reported.Concomitant medication and premedication included gemfibrozil, ibuprofen, cetirizine, ondansetron, and vancomycin.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.The date the patient initiated treatment with the non-medtronic product was updated from (b)(6) 2016 to (b)(6) 2016.As of 2022-mar-18, the outcome of this event has been updated from resolving/recovering to resolved/recovered.It was again noted that the patient's device related infection was related to the patient's intracerebral ventriculostomy (icv) device.

• Brand Name: RES 44200 VENTRICULOSTOMY BH 6MM REG IMP
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13826083
• MDR Text Key: 288099800
• Report Number: 2021898-2022-00071
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 44200
• Device Catalogue Number: 44200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 57 KG